DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant’s amendments to claims 1-5, 9, 11, 14, and 16-26 filed 01/28/2026 is acknowledged by the examiner.
Claims 6-7, 10, 12-13, 15, and 27 remain cancelled.
Claims 1-5, 8-9, 11, 14, and 16-26 are currently pending and are under examination.
Response to Arguments
Applicant's arguments filed 01/28/2026 have been fully considered but they are not persuasive.
Applicant’s argument regarding 112(b) rejections: The claimed parameters are subject to routine measurement variability and accepted tolerances in the art, and the specification provides objective guidance through functional constraints and disclosed ranges. Moreover, the term “about” and “approximately” are used throughout the specification. A person of ordinary skill in the art would readily understand the meaning of these terms in the claims when taken in view of the specification.
Examiner’s response: "Claim language employing terms of degree has long been found definite where it provided enough certainty to one of skill in the art when read in the context of the invention." Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1370, 112 USPQ2d 1188, 1192-93 (Fed. Cir. 2014) (citing Eibel Process Co. v. Minnesota & Ontario Paper Co., 261 U.S. 45, 65-66 (1923) (finding ‘substantial pitch’ sufficiently definite because one skilled in the art ‘had no difficulty … in determining what was the substantial pitch needed’ to practice the invention)). Thus, when a term of degree is used in the claim, the examiner should determine whether the specification provides some standard for measuring that degree. Therefore, based on the specification, it is unclear as to what extent “about” and “approximately” mean, for example in claim 5, it is unclear whether 1300 ng/ml is considered to read on “about 1250 ng/ml” as it is unclear what range can be read on “about”.
Applicant’s argument: The Office Action’s proposed modification appears to be based solely on Applicant’s disclosure as a roadmap, which constitutes impermissible hindsight reconstruction. Tal provides no teaching or suggestion of the claimed baseline mean serum concentrations. There is no articulated reasoning with rational underpinning explaining why a person of ordinary skill would have combined these references to arrive at a device that allows for baseline-corrected mean concentration. The Office Action provides no explanation as to why the modification would have had a reasonable expectation of success, particularly given the technical challenges associated with baseline correction of serum copper concentrations. As explained in the Materials and Methods of Prema, 148 women did not use any form of contraception, and 95 women used a Lippes Loop. A Lippes Loop is not an analogous device. A Lippes Loop is an intrauterine device having an entirely different configuration than the instantly claimed contraceptive device. Prema was undertaken to determine whether intrauterine, long-term use of copper resulted in copper toxicity, not whether copper was an effective contraceptive method. Moreover, Prema does not teach a device. Prema merely studies the effects of entirely of long-term intrauterine copper exposure by proxy of a different device, the Lippes Loop. Nothing in Prema would teach or suggest to a person of ordinary skill in the art how to modify Tal to arrive at the instantly claimed device with the recited baseline mean serum concentrations.
Examiner’s response: In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Further, in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Tal does not have to explicitly disclose teaching or suggestion of the claimed baseline mean serum concentrations, as the motivation or teaching to combine a reference does not have to come from the prior art. The statement for the motivation to combine Tal in view of Prema is given throughout the office action, and the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, F.2d 413, 208 USPQ 871 (CCPA 1981). Further, under the Materials and Methods section of Prema starting on Pg. 32 and as stated in the rejection, there were also women who had used a Cu-T200 Copper IUD, which is an analogous intrauterine device to the instant invention. The office action does not rely on the Lippes Loop, therefore, the arguments regarding the Lippes Loop is moot. Therefore, the combination of Tal in view of Prema still stands.
Applicant’s argument: The Office Action further asserts “Applicant appears to have placed no criticality on the claimed range.” However, criticality is asserted throughout the specification. The claimed range is not an arbitrary optimization but is tied to the baseline-corrected computation.
Examiner’s response: Applicants can rebut a prima facie case of obviousness by showing the criticality of the range. "The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." See MPEP 2144.05 III A. Therefore, the applicant does not explain how the particular ranges claimed achieves unexpected results relative to the ranges taught by Prema.
Applicant’s argument regarding claim 11 and 14: Tal merely states that IUD 2100 may be altered to include copper delivery but provides no guidance regarding the form, placement, or amount of copper, nor any recognition that copper surface area should be limited to achieve a particular physiological effect. Prema likewise does not disclose or suggest a maximum exposed coper surface area, nor does it teach that restricting copper exposure would maintain contraceptive efficacy while reducing bleeding side effects. The Examiner’s conclusion relies on impermissible hindsight. Accordingly, the cited references do not provide a motivation to combine with reasonable expectation of success.
Examiner’s response: In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Further, Tal explicitly discloses in another embodiment (IUD 2300, Figs. 6A-6B of Tal) the form, placement, and amount of copper, and the copper surface area should be limited to achieve a particular physiological effect. Therefore, the combination still stands.
Claim Objections
Claims 1 and 14 are objected to because of the following informalities:
Regarding claim 1, “when the two tissue contact surfaces are forced toward one another by an inner wall of a uterus” in lines 6-7 should be recited as “when the two tissue contact surfaces are configured to be forced toward one another by an inner wall of a uterus”.
Regarding claim 14, “the tissue contact surfaces” in line 5 should be recited as “the two tissue contact surfaces”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 8, 9, 11, 14, and 16-26 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “about” in claim 1 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As no explicit definition is given in Applicant’s specification, the Examiner has defined “about 500 ng/ml to about 2000 ng/ml” as “500 ng/ml to 2000 ng/ml” with minor deviations.
The term “about” in claim 2 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As no explicit definition is given in Applicant’s specification, the Examiner has defined “about 1100 ng/ml to about 1500 ng/ml” as “1100 ng/ml to 1500 ng/ml” with minor deviations.
The term “about” in claim 3 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As no explicit definition is given in Applicant’s specification, the Examiner has defined “about 500 ng/ml to about 2000 ng/ml” as “500 ng/ml to 2000 ng/ml” with minor deviations.
The term “about” in claim 4 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As no explicit definition is given in Applicant’s specification, the Examiner has defined “about 1200 ng/ml to about 1300 ng/ml” as “1200 ng/ml to 1300 ng/ml” with minor deviations.
The term “about” in claim 5 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As no explicit definition is given in Applicant’s specification, the Examiner has defined “about 1250 ng/ml” as “1250 ng/ml” with minor deviations.
The term “approximately” in claim 8 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As no explicit definition is given in Applicant’s specification, the Examiner has defined “a width approximately equal” as “a width equal” with minor deviations.
The term “about” in claim 9 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As no explicit definition is given in Applicant’s specification, the Examiner has defined “about 2.70 mm and about 2.90 mm” as “2.70 mm and 2.90 mm” with minor deviations.
The term “approximately” in claim 11 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As no explicit definition is given in Applicant’s specification, the Examiner has defined “approximately 200 square millimeters” as “200 square millimeters” with minor deviations.
The term “about” in claim 16 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As no explicit definition is given in Applicant’s specification, the Examiner has defined “about 5 ng/ml to about 150 ng/ml” as “5 ng/ml to 150 ng/ml” with minor deviations.
The term “about” in claim 17 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As no explicit definition is given in Applicant’s specification, the Examiner has defined “about 30 ng/ml to about 125 ng/ml” as “30 ng/ml to 135 ng/ml” with minor deviations.
The term “about” in claim 18 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As no explicit definition is given in Applicant’s specification, the Examiner has defined “about 50 ng/ml to about 100 ng/ml” as “50 ng/ml to 100 ng/ml” with minor deviations.
The term “about” in claim 19 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As no explicit definition is given in Applicant’s specification, the Examiner has defined “about 80 ng/ml” as “80 ng/ml” with minor deviations.
The term “about” in claim 20 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As no explicit definition is given in Applicant’s specification, the Examiner has defined “about 50 day*ng/ml to about 4000 day*ng/ml” as “50 day*ng/ml to 4000 day*ng/ml” with minor deviations.
The term “about” in claim 21 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As no explicit definition is given in Applicant’s specification, the Examiner has defined “about 200 day*ng/ml to about 3500 day*ng/ml” as “200 day*ng/ml to 3500 day*ng/ml” with minor deviations.
The term “about” in claim 22 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As no explicit definition is given in Applicant’s specification, the Examiner has defined “about 400 day*ng/ml to about 3000 day*ng/ml” as “400 day*ng/ml to 3000 day*ng/ml” with minor deviations.
The term “about” in claim 23 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As no explicit definition is given in Applicant’s specification, the Examiner has defined “about 750 day*ng/ml to about 2000 day*ng/ml” as “750 day*ng/ml to 2000 day*ng/ml” with minor deviations.
The term “about” in claim 24 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As no explicit definition is given in Applicant’s specification, the Examiner has defined “about 1250 day*ng/ml to about 2000 day*ng/ml” as “1250 day*ng/ml to 2000 day*ng/ml” with minor deviations.
The term “about” in claim 25 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As no explicit definition is given in Applicant’s specification, the Examiner has defined “about 1500 day*ng/ml to about 2000 day*ng/ml” as “1500 day*ng/ml to 2000 day*ng/ml” with minor deviations.
The term “about” in claim 26 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As no explicit definition is given in Applicant’s specification, the Examiner has defined “about 1750 day*ng/ml” as “1750 day*ng/ml” with minor deviations.
The remaining claims are rejected due to their dependency.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-5, 8-9, 11, 14 and 16-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tal et al. (referred to as “Tal”) (US 2014/0048073 A1) in view of Prema et al. (referred to as “Prema”) (“Serum Copper in Long-term Users of Copper Intrauterine Devices”).
Regarding claim 1, Tal discloses a shape memory, intrauterine, contraceptive device (22100) (see Fig. 3 and [0066]; IUD 2100 is an intrauterine contraceptive device and includes elongate shape memory member 2102), comprising: two tissue contact surfaces (2108a, 2108b) at or near opposing ends of the device (2100) (see Fig. 3 and [0066]; tissue contact surfaces 2108a, 2108b, or also called “end points,” are at opposing ends of the IUD 2100); an expandable middle portion (2104) between the tissue contact surfaces (2108a, 2108b) (see Fig. 3 and [0066]; expandable middle portion 2104 is between the two tissue contact surfaces 2108a, 2108b); and a spring portion (2106) at or near a midpoint of the elongate member (2102) (see Fig. 3 and [0066]; spring portion 2106 is at a midpoint of the elongate member 2102 as seen in Fig. 3); wherein the contraceptive device (2100) is configured to move from a first, default configuration when unconstrained to a second, partially collapsed configuration when the two tissue contact surfaces (2108a, 2108b) are forced toward one another by an inner wall of a uterus (see Figs. 3-4B and [0067]-[0068], and [0071]; Figs. 3 and 4A shows the IUD 2100 in its first, default configuration in which IUD 2100 is unconstrained, and then IUD 2100 is configured to move to a second, partially collapsed configuration in which the two tissue contact surfaces 2108a, 2108b are forced toward one another by an inner wall of a uterus, as best described in [0071]), wherein the expandable middle portion (2104) is configured to expand into a second shape such that it contacts the inner wall of the uterus to help prevent migration of the contraceptive device (2100) out of the uterus (see Figs. 3-4B and [0071]; the expandable middle portion 2104 is configured to expand into a second shape, as seen from Figs. 4A to 4B, such that the expandable middle portion 2104 contacts the inner wall of the uterus to help prevent migration of the IUD 2100 out of the uterus).
Tal is silent on at least one substance delivery member and wherein the contraceptive device allows for baseline mean serum concentrations of a substance of about 500 ng/ml to about 2000 ng/ml.
However, Tal further teaches in another analogous embodiment of a shape memory, intrauterine, contraceptive device (2300) (see Figs. 6A-6B and [0079]; IUD 2300), and at least one substance delivery member (2312) (see Figs. 6A-6B and [0080]; copper sleeves 2312 of IUD 2300 are substance delivery members as cooper sleeves 2312 deliver copper which is a substance to the uterus), providing an effective IUD without as many bleeding side effects (see [0076]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the intrauterine contraceptive device (IUD 2100 of Tal) in the device of Tal with at least one substance delivery member (2312), as Tal discloses that IUD 2100 may be altered to include delivery of copper, see [0074] of Tal, as taught by another embodiment of Tal to have provided an improved intrauterine contraceptive device that provides an effective IUD without as many bleeding side effects (see [0076]).
Tal discloses the invention as discussed above.
Tal is silent on wherein the contraceptive device allows for baseline mean serum concentrations of a substance of about 500 ng/ml to about 2000 ng/ml.
However, Prema teaches an analogous intrauterine, contraceptive device (Cu-T200 IUD; see Pg. 32 under Materials and Methods header), and wherein the device (Cu-T200 IUD) allows for baseline mean serum concentrations of a substance of about 500 ng/ml to about 2000 ng/ml (see Table 2 on Pg. 33; the Cu-T200 IUD allows for baseline mean serum concentrations of copper, which is a substance, of 110µg/dl which is equivalent to 1100 ng/ml, as this is the initial or baseline concentration of copper in a user, and thus falls within the claimed range), providing an IUD that is non-hormonal, effective, and safe.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intrauterine contraceptive device (IUD 2100) of Tal to allow for baseline mean serum concentrations of a substance of about 500 ng/ml to about 2000 ng/ml as taught by Prema to have provided an improved intrauterine contraceptive device that is non-hormonal, effective, and safe.
Regarding claim 2, Tal in view of Prema discloses the invention as discussed in claim 1. Tal in view of Prema further discloses wherein the contraceptive device allows for baseline mean serum concentrations of about 1100 ng/ml to about 1500 ng/ml (see Table 2 on Pg. 33 of Prema; as previously modified above, the Cu-T200 IUD allows for baseline mean serum concentrations of copper, which is a substance, of 110µg/dl which is equivalent to 1100 ng/ml, and thus falls within the claimed range).
Regarding claim 3, Tal in view of Prema discloses the invention as discussed in claim 1. Tal in view of Prema further discloses wherein the contraceptive device allows for baseline mean serum concentrations of about 1200 ng/ml to about 1400 ng/ml (see Table 2 on Pg. 33 of Prema; as previously modified above, the Cu-T200 IUD allows for baseline mean serum concentrations of copper, which is a substance, of 110µg/dl +/- 16.3, which means it can be 93.7 ng/dl to 1263 ng/dl which means it can be 1263 ng/dl, and thus falls within the claimed range).
Regarding claim 4, Tal in view of Prema discloses the invention as discussed in claim 1. Tal in view of Prema further discloses wherein the contraceptive device allows for baseline mean serum concentrations of about 1200 ng/ml to about 1300 ng/ml (see Table 2 on Pg. 33 of Prema; as previously modified above, the Cu-T200 IUD allows for baseline mean serum concentrations of copper, which is a substance, of 110 +/- 16.3 µg/dl, and thus allows for baseline mean serum concentrations of 110+16.3 = 126.3 µg/dl which is equivalent to 1263 ng/ml, and thus falls within the claimed range).
Regarding claim 5, Tal in view of Prema discloses the invention as discussed in claim 1. Tal in view of Prema further discloses wherein the device allows for baseline mean serum concentrations of about 1250 ng/ml (see Table 2 on Pg. 33 of Prema; as previously modified above, the Cu-T200 IUD allows for baseline mean serum concentrations of copper, which is a substance, of 110 +/- 16.3 µg/dl, and thus allows for baseline mean serum concentrations of 126.3 µg/dl which is equivalent to 1263 ng/ml, which is about 1250 ng/ml).
Regarding claim 8, Tal in view of Prema discloses the invention as discussed in claim 1. Tal in view of Prema further discloses wherein the middle portion (2104 of Tal) is expandable, in the second shape, to a width approximately equal to a distance between the two tissue contact surfaces (2108a, 2108b of Tal) (see Figs. 3-4B of Tal and [0022] of Tal, and [0071] of Tal; the middle portion 2104 of Tal is expandable in the second shape to a width approximately equal to a distance between the two tissue contact surfaces 2108a, 2108b of Tal).
Regarding claim 9, Tal in view of Prema discloses the invention as discussed in claim 1. Tal in view of Prema further discloses wherein the contraceptive device (IUD 2100 of Tal) is compressible into a third, fully collapsed configuration for positioning within a delivery sheath having an inner diameter of between about 2.70 mm and about 2.90 mm (see Fig. 3 of Tal and [0070] of Tal; the IUD 2100 of Tal is compressible into a third, fully collapsed configuration for positioning within a delivery sheath having an inner diameter of between about 2.70 mm and about 2.90 mm).
Regarding claim 11, Tal in view of Prema discloses the invention as discussed in claim 1. Tal in view of Prema further discloses wherein the substance is copper (see [0080] of Tal; as previously modified above, see claim 1, the copper sleeves 2312 of Tal delivers the substance copper).
Tal further teaches in another analogous embodiment (see Figs. 6A-6B and [0079]-[0080]; IUD 2300) wherein a total exposed surface area of the at least one substance delivery member (2312) is no more than approximately 200 square millimeters (see Figs. 6A-6B and [0080]; the total exposed surface area of the copper sleeves 2312 is no more than about 200 square millimeters), providing a large enough surface area of copper to reduce risk of abnormal bleeding or other side effects while still acting as a contraceptive (see [0006]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one substance delivery member (2312 of Tal) in the device of Tal in view of Prema to have a total exposed surface area of no more than approximately 200 square millimeters as taught by another embodiment of Tal to have provided an improved contraceptive device that provides a large enough surface area of copper to reduce risk of abnormal bleeding or other side effects while still acting as a contraceptive (see [0006]).
Regarding claim 14, Tal in view of Prema discloses the invention as discussed in claim 11. Tal in view of Prema further discloses wherein the contraceptive device (2100 of Tal) comprises a shape memory wire (see [0022] and [0069] of Tal; the IUD 2100 of Tal is a shape memory wire).
Tal further teaches in another analogous embodiment (see Figs. 6A-6B; IUD 2300) wherein the at least one substance delivery member (2312) comprises: a first copper sleeve (2312) disposed over the shape memory wire at or near a first one of the two tissue contact surfaces (2308a) (see Figs. 6A-6B and [0080]; copper sleeves 2312 are disposed over the shape memory wire of nitinol, see [0028] and [0079], near tissue contact surface 2308a); a second copper sleeve (2312 of Tal) disposed over the shape memory wire at or near a second of the tissue contact surfaces (2308b) (see Figs. 6A-6B and [0080]; the other copper sleeves 2312 on the opposing side are disposed over the shape memory wire of nitinol, see [0028] and [0079], near tissue contact surface 2308b); and a third copper sleeve (2314) disposed over the shape memory wire at or near the spring portion (2306) (see Figs. 6A-6B and [0080]; copper sleeve 2314 is disposed over the shape memory wire of nitinol, see [0028] and [0079], and is near spring portion 2306), providing an effective IUD without as many bleeding side effects (see [0076]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intrauterine contraceptive device (2100 of Tal) in the device of Tal in view of Prema further in view of Tal such that a first copper sleeve is disposed over the shape memory wire at or near a first one of the tissue contact surfaces; a second copper sleeve disposed over the shape memory wire at or near second one of the tissue contact surfaces; and a third copper sleeve disposed over the shape memory wire at or near the spring portion, as Tal discloses that IUD 2100 may be altered to include delivery of copper, see [0074] of Tal, as taught by another embodiment of Tal to have provided an improved intrauterine contraceptive device that provides an effective IUD without as many bleeding side effects (see [0076]).
Regarding claim 16, Tal in view of Prema discloses the invention as discussed in claim 1.
Although Tal in view of Prema does not explicitly disclose wherein the contraceptive device allows for a baseline-corrected mean serum copper Cmean of about 5 ng/ml to about 150 ng/ml, it is noted that the Applicant appears to have placed no criticality on the claimed range (see [0088] of Applicant’s specification on Pg. 38), and therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intrauterine contraceptive device (2100 of Tal) in the device of Tal in view of Prema to allow for a baseline-corrected mean serum copper Cmean of about 5 ng/ml to about 150 ng/ml to achieve a reasonable expectation of success and for the purpose of providing an IUD that is non-hormonal, effective, and safe, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235.
Regarding claim 17, Tal in view of Prema discloses the invention as discussed in claim 1.
Although Tal in view of Prema does not explicitly disclose wherein the contraceptive device allows for a baseline-corrected mean serum copper Cmean of about 30 ng/ml to about 125 ng/ml, it is noted that the Applicant appears to have placed no criticality on the claimed range (see [0088] of Applicant’s specification on Pg. 38), and therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intrauterine contraceptive device (2100 of Tal) in the device of Tal in view of Prema to allow for a baseline-corrected mean serum copper Cmean of about 30 ng/ml to about 125 ng/ml to achieve a reasonable expectation of success and for the purpose of providing an IUD that is non-hormonal, effective, and safe, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235.
Regarding claim 18, Tal in view of Prema discloses the invention as discussed in claim 1.
Although Tal in view of Prema does not explicitly disclose wherein the contraceptive device allows for a baseline-corrected mean serum copper Cmean of about 50 ng/ml to about 100 ng/ml, it is noted that the Applicant appears to have placed no criticality on the claimed range (see [0088] of Applicant’s specification on Pg. 38), and therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intrauterine contraceptive device (2100 of Tal) in the device of Tal in view of Prema to allow for a baseline-corrected mean serum copper Cmean of about 50 ng/ml to about 100 ng/ml to achieve a reasonable expectation of success and for the purpose of providing an IUD that is non-hormonal, effective, and safe, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235.
Regarding claim 19, Tal in view of Prema discloses the invention as discussed in claim 1.
Although Tal in view of Prema does not explicitly disclose wherein the contraceptive device allows for a baseline-corrected mean serum copper Cmean of about 80 ng/ml, it is noted that the Applicant appears to have placed no criticality on the claimed range (see [0088] of Applicant’s specification on Pg. 38), and therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intrauterine contraceptive device (2100 of Tal) in the device of Tal in view of Prema to allow for a baseline-corrected mean serum copper Cmean of about 80 ng/ml to achieve a reasonable expectation of success and for the purpose of providing an IUD that is non-hormonal, effective, and safe, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235.
Regarding claim 20, Tal in view of Prema discloses the invention as discussed in claim 1.
Although Tal in view of Prema does not explicitly disclose wherein the contraceptive device allows for a baseline-corrected mean serum copper AUC 0-56 days of about 50 day*ng/ml to about 4000 day*ng/ml, it is noted that the Applicant appears to have placed no criticality on the claimed range (see [0089] of Applicant’s specification on Pgs. 38-39), and therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intrauterine contraceptive device (2100 of Tal) in the device of Tal in view of Prema to allow for a baseline-corrected mean serum copper AUC 0-56 days of about 50 day*ng/ml to about 4000 day*ng/ml to achieve a reasonable expectation of success and for the purpose of providing an IUD that is non-hormonal, effective, and safe, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235.
Regarding claim 21, Tal in view of Prema discloses the invention as discussed in claim 1.
Although Tal in view of Prema does not explicitly disclose wherein the contraceptive device allows for a baseline-corrected mean serum copper AUC 0-56 days of about 200 day*ng/ml to about 3500 day*ng/ml, it is noted that the Applicant appears to have placed no criticality on the claimed range (see [0089] of Applicant’s specification on Pgs. 38-39), and therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intrauterine contraceptive device (2100 of Tal) in the device of Tal in view of Prema to allow for a baseline-corrected mean serum copper AUC 0-56 days of about 200 day*ng/ml to about 3500 day*ng/ml to achieve a reasonable expectation of success and for the purpose of providing an IUD that is non-hormonal, effective, and safe, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235.
Regarding claim 22, Tal in view of Prema discloses the invention as discussed in claim 1.
Although Tal in view of Prema does not explicitly disclose wherein the contraceptive device allows for a baseline-corrected mean serum copper AUC 0-56 days of about 400 day*ng/ml to about 3000 day*ng/ml, it is noted that the Applicant appears to have placed no criticality on the claimed range (see [0089] of Applicant’s specification on Pgs. 38-39), and therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intrauterine contraceptive device (2100 of Tal) in the device of Tal in view of Prema to allow for a baseline-corrected mean serum copper AUC 0-56 days of about 400 day*ng/ml to about 3000 day*ng/ml to achieve a reasonable expectation of success and for the purpose of providing an IUD that is non-hormonal, effective, and safe, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235.
Regarding claim 23, Tal in view of Prema discloses the invention as discussed in claim 1.
Although Tal in view of Prema does not explicitly disclose wherein the contraceptive device allows for a baseline-corrected mean serum copper AUC 0-56 days of about 750 day*ng/ml to about 2000 day*ng/ml, it is noted that the Applicant appears to have placed no criticality on the claimed range (see [0089] of Applicant’s specification on Pgs. 38-39), and therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intrauterine contraceptive device (2100 of Tal) in the device of Tal in view of Prema to allow for a baseline-corrected mean serum copper AUC 0-56 days of about 750 day*ng/ml to about 2000 day*ng/ml to achieve a reasonable expectation of success and for the purpose of providing an IUD that is non-hormonal, effective, and safe, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235.
Regarding claim 24, Tal in view of Prema discloses the invention as discussed in claim 1.
Although Tal in view of Prema does not explicitly disclose wherein the contraceptive device allows for a baseline-corrected mean serum copper AUC 0-56 days of about 1250 day*ng/ml to about 2000 day*ng/ml, it is noted that the Applicant appears to have placed no criticality on the claimed range (see [0089] of Applicant’s specification on Pgs. 38-39), and therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intrauterine contraceptive device (2100 of Tal) in the device of Tal in view of Prema to allow for a baseline-corrected mean serum copper AUC 0-56 days of about 50 day*ng/ml to about 4000 day*ng/ml to achieve a reasonable expectation of success and for the purpose of providing an IUD that is non-hormonal, effective, and safe, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235.
Regarding claim 25, Tal in view of Prema discloses the invention as discussed in claim 1.
Although Tal in view of Prema does not explicitly disclose wherein the contraceptive device allows for a baseline-corrected mean serum copper AUC 0-56 days of about 1500 day*ng/ml to about 2000 day*ng/ml, it is noted that the Applicant appears to have placed no criticality on the claimed range (see [0089] of Applicant’s specification on Pgs. 38-39), and therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intrauterine contraceptive device (2100 of Tal) in the device of Tal in view of Prema to allow for a baseline-corrected mean serum copper AUC 0-56 days of about 1500 day*ng/ml to about 2000 day*ng/ml to achieve a reasonable expectation of success and for the purpose of providing an IUD that is non-hormonal, effective, and safe, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235.
Regarding claim 26, Tal in view of Prema discloses the invention as discussed in claim 1.
Although Tal in view of Prema does not explicitly disclose wherein the contraceptive device allows for a baseline-corrected mean serum copper AUC 0-56 days of about 1750 day*ng/ml, it is noted that the Applicant appears to have placed no criticality on the claimed range (see [0089] of Applicant’s specification on Pgs. 38-39), and therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intrauterine contraceptive device (2100 of Tal) in the device of Tal in view of Prema to allow for a baseline-corrected mean serum copper AUC 0-56 days of about 1750 day*ng/ml to achieve a reasonable expectation of success and for the purpose of providing an IUD that is non-hormonal, effective, and safe, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ROBIN HAN/Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786
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